Use of concomitant G-CSF in maintaining efficacious dose and safe delivery of docetaxel in combination with darolutamide in ARASENS: A phase III study.
[BACKGROUND] We assessed the impact of granulocyte colony-stimulating factor (G-CSF) use and docetaxel relative dose intensity (RDI) on the safety profile of the ARASENS (NCT02799602) triplet regimen
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APA
Ong M, Suzuki H, et al. (2026). Use of concomitant G-CSF in maintaining efficacious dose and safe delivery of docetaxel in combination with darolutamide in ARASENS: A phase III study.. European journal of cancer (Oxford, England : 1990), 236, 116264. https://doi.org/10.1016/j.ejca.2026.116264
MLA
Ong M, et al.. "Use of concomitant G-CSF in maintaining efficacious dose and safe delivery of docetaxel in combination with darolutamide in ARASENS: A phase III study.." European journal of cancer (Oxford, England : 1990), vol. 236, 2026, pp. 116264.
PMID
41655462
Abstract
[BACKGROUND] We assessed the impact of granulocyte colony-stimulating factor (G-CSF) use and docetaxel relative dose intensity (RDI) on the safety profile of the ARASENS (NCT02799602) triplet regimen with darolutamide in patients with metastatic hormone-sensitive prostate cancer.
[METHODS] Patients were randomized to darolutamide 600 mg orally twice daily or placebo, with androgen deprivation therapy (ADT) and docetaxel. Baseline characteristics, G-CSF use, and safety were analyzed according to docetaxel RDI (≤85 % vs >85 %).
[RESULTS] Of 1273 patients with docetaxel RDI data (darolutamide n = 637; placebo n = 636), > 97 % received an efficacious dose of docetaxel (RDI >80 %). Patient demographics and baseline disease characteristics were generally similar between RDI subgroups; > 60 % of patients with RDI ≤ 85 % were from the Asia-Pacific region. Concomitant G-CSF, with/without docetaxel dose modification, was used in 42.4 % (darolutamide) and 44.6 % (placebo) of patients, mainly as secondary prophylaxis; 61.3 % (darolutamide) and 64.4 % (placebo) received both docetaxel dose modifications and G-CSF. Grade ≥ 3 treatment-emergent adverse events (TEAEs), grade ≥ 3 neutropenia, and grade ≥ 3 febrile neutropenia were higher with docetaxel RDI ≤ 85 %, but docetaxel discontinuation rates were similar between subgroups (RDI ≤85 %: darolutamide 7.2 %, placebo 10.8 %; RDI >85 %: darolutamide 8.1 %, placebo 10.5 %). TEAEs leading to docetaxel dose modification were more frequent with docetaxel RDI ≤ 85 % (darolutamide 92.8 %; placebo 97.3 %) versus RDI > 85 % (darolutamide 26.0 %; placebo 25.3 %).
[CONCLUSION] Appropriate docetaxel dose modifications and early G-CSF use allowed almost all patients to receive an efficacious dose of docetaxel in combination with darolutamide and ADT and may prevent neutropenic complications in patients receiving docetaxel.
[PRIOR PRESENTATION] Previously presented at the 2025 American Society of Clinical Oncology Genitourinary Cancers Symposium, San Francisco, CA.
[METHODS] Patients were randomized to darolutamide 600 mg orally twice daily or placebo, with androgen deprivation therapy (ADT) and docetaxel. Baseline characteristics, G-CSF use, and safety were analyzed according to docetaxel RDI (≤85 % vs >85 %).
[RESULTS] Of 1273 patients with docetaxel RDI data (darolutamide n = 637; placebo n = 636), > 97 % received an efficacious dose of docetaxel (RDI >80 %). Patient demographics and baseline disease characteristics were generally similar between RDI subgroups; > 60 % of patients with RDI ≤ 85 % were from the Asia-Pacific region. Concomitant G-CSF, with/without docetaxel dose modification, was used in 42.4 % (darolutamide) and 44.6 % (placebo) of patients, mainly as secondary prophylaxis; 61.3 % (darolutamide) and 64.4 % (placebo) received both docetaxel dose modifications and G-CSF. Grade ≥ 3 treatment-emergent adverse events (TEAEs), grade ≥ 3 neutropenia, and grade ≥ 3 febrile neutropenia were higher with docetaxel RDI ≤ 85 %, but docetaxel discontinuation rates were similar between subgroups (RDI ≤85 %: darolutamide 7.2 %, placebo 10.8 %; RDI >85 %: darolutamide 8.1 %, placebo 10.5 %). TEAEs leading to docetaxel dose modification were more frequent with docetaxel RDI ≤ 85 % (darolutamide 92.8 %; placebo 97.3 %) versus RDI > 85 % (darolutamide 26.0 %; placebo 25.3 %).
[CONCLUSION] Appropriate docetaxel dose modifications and early G-CSF use allowed almost all patients to receive an efficacious dose of docetaxel in combination with darolutamide and ADT and may prevent neutropenic complications in patients receiving docetaxel.
[PRIOR PRESENTATION] Previously presented at the 2025 American Society of Clinical Oncology Genitourinary Cancers Symposium, San Francisco, CA.
MeSH Terms
Humans; Docetaxel; Male; Granulocyte Colony-Stimulating Factor; Prostatic Neoplasms; Aged; Antineoplastic Combined Chemotherapy Protocols; Middle Aged; Pyrazoles; Double-Blind Method; Aged, 80 and over